PROJECT ABSTRACT This CRP SBIR project aims to launch to market a point-of-care (POC) test to measure patient adherence to Pre-exposure Prophylaxis (PrEP) as a prevention against HIV infection in people known to be at risk of HIV exposure, and to antiretroviral therapy (ART) as treatment to HIV. HIV contributes to millions of infections and deaths per year and tens of billions of dollars in healthcare costs around the world. PrEP is 99% effective at preventing HIV infection if taken daily, but adherence in poor. PrEP is recommended by the CDC in populations at a high risk of HIV infection, which include men who have sex with men, intravenous drug users, and serodiscordant couples. Similarly, ART, can be effective and suppress viral load when following the dosing schedule. Due to poor adherence, not only are patients inappropriately treated, the chance of developing resistant strains is increased. Drug adherence monitoring is well known to improve drug compliance, but currently there are no commercial products for rapid adherence monitoring of PrEP and ART. To be acceptable to patients and feasible in the physician workflow, this adherence test needs to be non-invasive, painless, inexpensive, easy to administer and provide rapid, accurate results. The UrSure Rapid Tenofovir POC test measures tenofovir (TFV), which is a component of PrEP and 90% of ART regimens. This project has successful completed Phase I where we demonstrated the feasibility of this approach. A novel TFV derivative was synthesized and used to produce novel anti-TFV antibodies that are specific and sensitive for TFV. In Phase II Year 1, we successfully developed a prototype with 100% sensitivity and 100% specificity and are currently in Phase II Year 2 verifying the LFIA performance to initiate technology transfer to our contract manufacturer. The POC test is noninvasive, painless, rapid (minutes to get a result) and inexpensive. It can be used during a clinic visit to measure PrEP adherence and, if appropriate, counsel patients on how to improve compliance. To be able to prepare the UrSure Tenofovir Rapid Test for commercialization, we are looking to engage in a CRP project. The objective of this CRP project is to conduct all validation studies required for the regulatory processes to allow our device to gain market approval globally. The Aims are to: 1) Evaluate intra and inter-lot validation and reproducibility of the scaled-up assay, 2) Conduct analytical validation studies for a FDA 510k submission, and 3) Conduct and submit flex studies to obtain CLIA-waiver. UrSure has relationships in place with experts and organizations with deep experience in regulatory process, especially in the diagnostics and medical devices. The final deliverables of this CRP project will be validated and scale-up manufacturing process, and submissions to obtain FDA pre-market approval, CLIA-waiver, and CE Mark approval. Successful completion of this CRP project will result in a validated prototype awaiting commercial launch globally.